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FRIDAY, Nov.
18, 2011 (HealthDay News) — The U.S. Food and Drug
Administration announced Friday that it is revoking Avastin's approval to treat
breast cancer because
the drug has not been shown to be safe and effective for that use.

The move follows
recommendations by an FDA advisory panel in June, which voted unanimously to
rescind approval of the drug for breast cancer treatment.

Avastin (bevacizumab) is
still approved for the treatment of certain types of colon, lung, kidney and
brain cancer, the agency said.

The FDA had approved
Avastin to be used in combination with the cancer drug paclitaxel for patients
with HER2-negative metastatic breast cancer who had not been treated with
chemotherapy.

That February 2008 approval
was given under the FDA's accelerated approval program, which permits a drug to
be approved based on data not sufficiently complete to permit full approval.

The accelerated approval
program is meant to provide earlier patient access to promising drugs for
serious or life-threatening conditions while researchers conduct clinical trials
to confirm a drug's safety and benefits.

The FDA said Friday that
its decision to revoke Avastin's approval for breast cancer treatment was based
on data from several clinical trials and thousands of pages' worth of data
submitted to a public docket, as well as the proceedings of the two-day
advisory committee hearing held in June.

"This was a difficult
decision. FDA recognizes how hard it is for patients and their families to cope
with metastatic
breast cancer and how great a need there is for more effective
treatments. But patients must have confidence that the drugs they take are both
safe and effective for their intended use," FDA Commissioner Dr. Margaret
A. Hamburg said in an agency news release.

"After reviewing the
available studies it is clear that women who take Avastin for metastatic breast
cancer risk potentially life-threatening side
effects without proof that the use of Avastin will provide a benefit,
in terms of delay in tumor growth, that would justify those risks," she
added. "Nor is there evidence that use of Avastin will either help them
live longer or improve their quality of life."

The risks associated with
Avastin include: severe high blood pressure; bleeding and hemorrhaging; heart
attack and heart failure; and the development of perforations in the nose,
stomach, intestines and other parts of the body, according to the FDA.

One breast cancer expert
called the FDA decision "throwing out the baby with the bathwater."

"There absolutely may
be subsets of carefully chosen breast cancer patients who benefit from Avastin,
and there are current and ongoing trials investigating the role of Avastin in
the treatment of certain aggressive types of tumor," said Dr. Elisa Port,
co-director of the Dubin Breast Center at Mount Sinai Medical Center in New
York City. "Perhaps results from these trials will help us better define
groups for whom there is a benefit so that treatment with Avastin can be
offered to patients who may benefit, without risking undue and potentially
harmful side effects for those who won't," she added.

Doctors can continue to
prescribe Avastin to patients "off-label," as they do other drugs.
But it's unlikely that insurance companies would cover off-label use of the
drug given its high price tag. Avastin costs more than $8,000 a month,
according to published reports.

The accelerated approval of
Avastin for breast cancer treatment was based on one study that suggested the
drug increased the length of time from the start of treatment to tumor
re-growth or death.

However, two studies completed
by Avastin's maker, Genentech, after the approval showed only a small effect on
tumor growth with no evidence that patients lived any longer or had a better
quality of life, compared to standard chemotherapy
alone.

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